MalnutritionNCT04202939
nutritionDay in Nursing Homes Worldwide: An International Audit and Registry on Nutrition and Outcome
An observational study of Malnutrition, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- nutrition
- Type of treatment
- Pill or oral medicine
- How many people
- 400,000 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2007to Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study evaluates nursing homes units and their residents who must be 50 years of age or older.
Who may be able to join
- nursing home resident
- minimum age: 50
- present on nursing home unit on nutritionDay
Who cannot join
- 49 years and under
- resident refused to participate in nutritionDay
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, 1090
Michael J Hiesmayr, MD, MSc, +43140400 ext. 41090, michael.hiesmayr@meduniwien.ac.at
Michael J Hiesmayr, MD, MSc
About this study
Official title: nutritionDay in Nursing Homes: An International Audit and Registry on Nutrition and Outcome
Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary:
- to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition,
- to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units,
- to allow comparison with other facilities (with similar profile) with the help of a benchmarking system,
- to assess the effectiveness of introduced changes in terms of quality management and quality improvement.
Read the detailed description
The study is a population-based, observational cross-section examination carried out on one day, and an outcome evaluation six months later. The examination should be repeated annually. Data is collected with the help of questionnaires. Anonymised data entry into the audit database is done with individual and anonymous center and unit-codes.
There are 2 questionnaires to complete on nutritionDay. The unit staff completes 1 questionnaire about structure of the unit and 1 questionnaire about resident characteristics.
- unit sheet: asks for nutrition related organisational and structural information on the unit.
- resident description: asks for general characteristics, diseases, care level, mobility and restrictions on food intake.
Outcome Evaluation: re-assesses the resident's outcome 6 months after nutritionDay (residence after 6 months, actual weight, and hospitalization). This questionnaire has to be completed 6 months after nutritionDay by the unit staff.
Participation rules:
- A user needs to register to nutritionDay as a member to the nutritionDay network. Each may choose a personal user name. Each user needs to provide a valid email address. After responding to a validation email the user is registered with the chosen user name. User details are stored on a system that is not connected to the nutritionDay registry at any time. One user may serve as contact for several units and centers.
- A user may order codes for participation for one or several centers and units. Access to the registry is only possible with a center code and unit code. These codes are selected from a list of random numbers.
Audit/registry recruitment plan:
Participation to the registry is voluntary. There is actually no participation fee. All necessary information can be obtained from a dedicated website (www.nutritionday.org). Participation can be promoted via international and national scientific societies, universities, health care organisations or governmental agencies as well as via advertisement at international and national congresses. T
Risk and benefit assessment:
The study implies no risk whatsoever for the residents. On some levels participation can even be expected to be beneficial:
- Direct benefit for residents through increased attention to nutritional problems.
- Raising awareness of decision-makers brought about by the decision-making process taking place prior to participating in the study and receiving the quality report of the nursing unit or facility.
- Increase awareness of the staff of nursing homes by participating in the study and the quality report. Pilot results suggest that in terms of the Hawthorne effect, just participation alone has a positive influence on nutrition management on nursing units.
- Since the project is planned for at least two years, it is possible to repeat the study after one year, to be able to monitor changes which were introduced as a result of the first report.
- Due to prior announcement on the nursing units, residents and their trustees are made aware of the issue of malnutrition and proper diet management. The nutritionDay in hospitals has shown that in many cases for the first time discussions between staff, patients and relatives on this subject were set in motion.
Documentation of the results of the study, data management and data security
All the necessary data for documentation of the study are entered on the questionnaires. On the study forms the nursing unit is identified by a numerical code, which is allocated after application from the audit facility. The questionnaires only include information on year of birth of the residents and their initials. If requested by the nursing units, to facilitate the evaluation of outcomes. the evaluation can be completed without the initials.
The data are entered online into the database from the facility. The coordination center does not have access at any time to documents that would influence the anonymity of the residents.
The data in the coordination center is checked for credibility prior to further evaluation. In the case of unclear or incomplete data, feedback to the responsible person on the nursing unit takes place and a possible correction of data is made. All data are analyzed anonymously, and the results are made available to each nursing unit so that the identity of the nursing unit, as well as the anonymity of the individual residents is assured.
Communication of Results Following data input of the resident's outcome, each nursing unit (the nutritionDay Project Leader person on the ward nursing unit responsible for organizing the nutritionDay and should be who is clearly identifiable by an e-mail address) receives the results compared to the whole project in the form of a quality report on nutritional intake and influencing factors.
The results of the study are published by the head of the study in a scientific journal and presented at scientific conferences.
Statistical Methods An analysis on survival with the target variable "death in nursing homes within six months" will be carried out. Existing risk factors are to be taken into account as covariant causes. Information on the time of admission to the nursing home and the time of death of the residents will be available.
In addition, the trend of weight development of the surviving residents between the nutritionDay and a half year thereafter will be recorded. The connection between nutritional status and weight on the nutritionDay and the course of weight thereafter of the surviving residents will be analyzed
- Conditions
- Malnutrition
- Being tested
- nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritionOther
Also called nursing home food, oral protein energy supplements, enteral nutrition, parenteral nutrition
type and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| nursing homes residents | all residents present in a nursing home unit on nutritionDay Receives: Other: nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependence of nutritional intake on nutritional status and risk factors
dependence of the outcome of nursing home residents' on their nutrient intake, their current nutritional status and risk factors (state of health, level of care
Measured: 180 days
Secondary outcomes (1)
Nutrition-related structural parameters
structural parameters (number and type of unit staff, implementation of regular nutrition screening
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study startFeb 2007
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism, Austrian Society for Clinical Nutrition
- Responsible party
- Principal investigator, Michael J. Hiesmayr, Medical University of Vienna
- Investigators
- Michael J Hiesmayr, MD, MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202939
- Sponsor's protocol ID
- 407/2005 (nursing homes)
- Status last verified
- Feb 2021
- First submitted
- 16 Dec 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Upon submission of a research proposal data anonymised data are shared with researcher. Each proposal is submitted to the supervisory board for approval.
Publications
Streicher M, Wirth R, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Dysphagia in Nursing Homes-Results From the NutritionDay Project. J Am Med Dir Assoc. 2018 Feb;19(2):141-147.e2. doi: 10.1016/j.jamda.2017.08.015. Epub 2017 Oct 10.
PubMed 29030310Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. nutritionDay in Nursing Homes-The Association of Nutritional Intake and Nutritional Interventions With 6-Month Mortality in Malnourished Residents. J Am Med Dir Assoc. 2017 Feb 1;18(2):162-168. doi: 10.1016/j.jamda.2016.08.021. Epub 2016 Oct 11.
PubMed 27742584Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Who receives oral nutritional supplements in nursing homes? Results from the nutritionDay project. Clin Nutr. 2017 Oct;36(5):1360-1371. doi: 10.1016/j.clnu.2016.09.005. Epub 2016 Sep 17.
PubMed 27692932Wirth R, Streicher M, Smoliner C, Kolb C, Hiesmayr M, Thiem U, Sieber CC, Volkert D. The impact of weight loss and low BMI on mortality of nursing home residents - Results from the nutritionDay in nursing homes. Clin Nutr. 2016 Aug;35(4):900-6. doi: 10.1016/j.clnu.2015.06.003. Epub 2015 Jun 19.
PubMed 26143743Valentini L, Schindler K, Schlaffer R, Bucher H, Mouhieddine M, Steininger K, Tripamer J, Handschuh M, Schuh C, Volkert D, Lochs H, Sieber CC, Hiesmayr M. The first nutritionDay in nursing homes: participation may improve malnutrition awareness. Clin Nutr. 2009 Apr;28(2):109-16. doi: 10.1016/j.clnu.2009.01.021. Epub 2009 Mar 5.
PubMed 19264381
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- nutritionDay in Nursing Homes: An International Audit and Registry on Nutrition and Outcome
- ClinicalTrials.gov ID
- NCT04202939
- Acronym / sponsor ID
- 407/2005 (nursing homes)
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- European Society for Clinical Nutrition and Metabolism, Austrian Society for Clinical Nutrition
- Study start
- Feb 2007 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to longer life expectancy, age-related changes and problems become more significant. The aging process is associated with loss of function and reduced performance. Age-related physiological changes in the regulation of nutrition intake and in the gastro-intestinal tract lead to deterioration of the nutritional status. Deterioration of the health status and of nutritional intake is further associated with chronic malnutrition, impaired quality of life, increased morbidity, mortality and long-term care. In order to ensure optimal nutritional care of nursing home residents and therefore have a lasting positive affect on their quality of life, morbidity and mortality, it is necessary:
- to collect data on the quality of nutritional care in nursing homes by means of a simple method that requires no specialization in data acquisition,
- to acquire knowledge on the prevalence of risk factors of malnutrition in nursing home residents in general and on individual nursing units, also in conjunction with the outcome after six months, and to forward the same to the individual nursing units,
- to allow comparison with other facilities (with similar profile) with the help of a benchmarking system,
- to assess the effectiveness of introduced changes in terms of quality management and quality improvement.
Detailed description
The study is a population-based, observational cross-section examination carried out on one day, and an outcome evaluation six months later. The examination should be repeated annually. Data is collected with the help of questionnaires. Anonymised data entry into the audit database is done with individual and anonymous center and unit-codes.
There are 2 questionnaires to complete on nutritionDay. The unit staff completes 1 questionnaire about structure of the unit and 1 questionnaire about resident characteristics.
- unit sheet: asks for nutrition related organisational and structural information on the unit.
- resident description: asks for general characteristics, diseases, care level, mobility and restrictions on food intake.
Outcome Evaluation: re-assesses the resident's outcome 6 months after nutritionDay (residence after 6 months, actual weight, and hospitalization). This questionnaire has to be completed 6 months after nutritionDay by the unit staff.
Participation rules:
- A user needs to register to nutritionDay as a member to the nutritionDay network. Each may choose a personal user name. Each user needs to provide a valid email address. After responding to a validation email the user is registered with the chosen user name. User details are stored on a system that is not connected to the nutritionDay registry at any time. One user may serve as contact for several units and centers.
- A user may order codes for participation for one or several centers and units. Access to the registry is only possible with a center code and unit code. These codes are selected from a list of random numbers.
Audit/registry recruitment plan:
Participation to the registry is voluntary. There is actually no participation fee. All necessary information can be obtained from a dedicated website (www.nutritionday.org). Participation can be promoted via international and national scientific societies, universities, health care organisations or governmental agencies as well as via advertisement at international and national congresses. T
Risk and benefit assessment:
The study implies no risk whatsoever for the residents. On some levels participation can even be expected to be beneficial:
- Direct benefit for residents through increased attention to nutritional problems.
- Raising awareness of decision-makers brought about by the decision-making process taking place prior to participating in the study and receiving the quality report of the nursing unit or facility.
- Increase awareness of the staff of nursing homes by participating in the study and the quality report. Pilot results suggest that in terms of the Hawthorne effect, just participation alone has a positive influence on nutrition management on nursing units.
- Since the project is planned for at least two years, it is possible to repeat the study after one year, to be able to monitor changes which were introduced as a result of the first report.
- Due to prior announcement on the nursing units, residents and their trustees are made aware of the issue of malnutrition and proper diet management. The nutritionDay in hospitals has shown that in many cases for the first time discussions between staff, patients and relatives on this subject were set in motion.
Documentation of the results of the study, data management and data security
All the necessary data for documentation of the study are entered on the questionnaires. On the study forms the nursing unit is identified by a numerical code, which is allocated after application from the audit facility. The questionnaires only include information on year of birth of the residents and their initials. If requested by the nursing units, to facilitate the evaluation of outcomes. the evaluation can be completed without the initials.
The data are entered online into the database from the facility. The coordination center does not have access at any time to documents that would influence the anonymity of the residents.
The data in the coordination center is checked for credibility prior to further evaluation. In the case of unclear or incomplete data, feedback to the responsible person on the nursing unit takes place and a possible correction of data is made. All data are analyzed anonymously, and the results are made available to each nursing unit so that the identity of the nursing unit, as well as the anonymity of the individual residents is assured.
Communication of Results Following data input of the resident's outcome, each nursing unit (the nutritionDay Project Leader person on the ward nursing unit responsible for organizing the nutritionDay and should be who is clearly identifiable by an e-mail address) receives the results compared to the whole project in the form of a quality report on nutritional intake and influencing factors.
The results of the study are published by the head of the study in a scientific journal and presented at scientific conferences.
Statistical Methods An analysis on survival with the target variable "death in nursing homes within six months" will be carried out. Existing risk factors are to be taken into account as covariant causes. Information on the time of admission to the nursing home and the time of death of the residents will be available.
In addition, the trend of weight development of the surviving residents between the nutritionDay and a half year thereafter will be recorded. The connection between nutritional status and weight on the nutritionDay and the course of weight thereafter of the surviving residents will be analyzed
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nursing homes residents | – | Other: nutritionall residents present in a nursing home unit on nutritionDay |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study evaluates nursing homes units and their residents who must be 50 years of age or older.
Key inclusion criteria (3 listed)
- nursing home resident
- minimum age: 50
- present on nursing home unit on nutritionDay
Key exclusion criteria (2 listed)
- 49 years and under
- resident refused to participate in nutritionDay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritionAlso: nursing home food, oral protein energy supplements, enteral nutrition, parenteral nutritiontype and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition | Other | nursing homes residents |
Primary outcome
Dependence of nutritional intake on nutritional status and risk factors
Time frame: 180 days
dependence of the outcome of nursing home residents' on their nutrient intake, their current nutritional status and risk factors (state of health, level of care
1 secondary outcome
Nutrition-related structural parameters
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 29030310Streicher M, Wirth R, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Dysphagia in Nursing Homes-Results From the NutritionDay Project. J Am Med Dir Assoc. 2018 Feb;19(2):141-147.e2. doi: 10.1016/j.jamda.2017.08.015. Epub 2017 Oct 10.
- Background: PubMed 27742584Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. nutritionDay in Nursing Homes-The Association of Nutritional Intake and Nutritional Interventions With 6-Month Mortality in Malnourished Residents. J Am Med Dir Assoc. 2017 Feb 1;18(2):162-168. doi: 10.1016/j.jamda.2016.08.021. Epub 2016 Oct 11.
- Background: PubMed 27692932Streicher M, Themessl-Huber M, Schindler K, Sieber CC, Hiesmayr M, Volkert D. Who receives oral nutritional supplements in nursing homes? Results from the nutritionDay project. Clin Nutr. 2017 Oct;36(5):1360-1371. doi: 10.1016/j.clnu.2016.09.005. Epub 2016 Sep 17.
- Background: PubMed 26143743Wirth R, Streicher M, Smoliner C, Kolb C, Hiesmayr M, Thiem U, Sieber CC, Volkert D. The impact of weight loss and low BMI on mortality of nursing home residents - Results from the nutritionDay in nursing homes. Clin Nutr. 2016 Aug;35(4):900-6. doi: 10.1016/j.clnu.2015.06.003. Epub 2015 Jun 19.
- Background: PubMed 19264381Valentini L, Schindler K, Schlaffer R, Bucher H, Mouhieddine M, Steininger K, Tripamer J, Handschuh M, Schuh C, Volkert D, Lochs H, Sieber CC, Hiesmayr M. The first nutritionDay in nursing homes: participation may improve malnutrition awareness. Clin Nutr. 2009 Apr;28(2):109-16. doi: 10.1016/j.clnu.2009.01.021. Epub 2009 Mar 5.
- nutritionDay project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon submission of a research proposal data anonymised data are shared with researcher. Each proposal is submitted to the supervisory board for approval.
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Hiesmayr, MD, MSc principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Hiesmayr, MD, MSc (+43140400 ext. 74940, michael.hiesmayr@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependence of nutritional intake on nutritional status and risk factors (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04202939, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.